# Reactogenicity

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Expected reaction to a vaccine

Mechanisms underlying the cause of reactogenicity symptoms

In [clinical trials](/source/Clinical_trials), **reactogenicity** is the capacity of a [vaccine](/source/Vaccine) to produce common, "expected" adverse reactions, especially excessive immunological responses and associated signs and symptoms, including fever and sore arm at the injection site. Other manifestations of reactogenicity typically identified in such trials include [bruising](/source/Bruising), [redness](/source/Redness), [induration](/source/Induration), and [swelling](/source/Swelling_(medical)).[1]

## Origin

The term reactogenicity was coined by the US [Food and Drug Administration](/source/Food_and_Drug_Administration) (FDA). All vaccines can induce reactogenicity, but reactogenicity is more likely in vaccines containing an [adjuvant](/source/Adjuvant), which is a chemical additive intended for enhancing the recipient's immune response to the [antigen](/source/Antigen) that is present in a vaccine. Reactogenicity describes the immediate short-term reactions of a system to vaccines and should not be confused with the long-term consequences [sequelae](/source/Sequela). Assessments of reactogenicity are carried out to evaluate the safety and usability of an experimental vaccine (see [Investigational New Drug](/source/Investigational_New_Drug)). It is unclear whether a higher degree of reactogenicity to a vaccine correlates with more severe [adverse events](/source/Adverse_event), which would require hospitalization or are life-threatening. Adverse events have been linked to a higher degree of reactogenicity; however, the links might have been coincidental. After assessing large databases relating to these events for many years, the FDA has not been able to make such a correlation.[1]

## Definition

Hypothesised link between the innate immune response induced by vaccination and reactogenicity

The US [National Institutes of Health](/source/National_Institutes_of_Health) (NIH) has provided the following definition of reactogenicity:[2]

Reactogenicity events are AEs that are common and known to occur for the intervention/investigational product being studied and should be collected in a standard, systematic format using a grading scale based on functional assessment or magnitude of reaction. Provide a definition of expected vs unexpected AEs and local vs systemic events, based on the risk profile of the intervention/investigational product. This information is found on the IB or package insert. Typically, reactogenicity AEs are solicited and collected on memory cards and documented on a reactogenicity CRF. This information comes from the participant who may also have a memory aid to help recollect their symptoms. The following is an example of a functional scale for assessing reactogenicity or other parameters not specifically listed in the toxicity table: 0 = Absence of the indicated symptom 1 = Mild (awareness of a symptom but the symptom is easily tolerated) 2 = Moderate (discomfort enough to cause interference with usual activity) 3 = Severe (incapacitating; unable to perform usual activities; requires absenteeism or bed rest) 4 = Life-threatening

## See also

- [Vaccine hesitancy](/source/Vaccine_hesitancy)

## References

1. ^ [***a***](#cite_ref-nature1_1-0) [***b***](#cite_ref-nature1_1-1) Hervé, Caroline; Laupèze, Béatrice; Del Giudice, Giuseppe; Didierlaurent, Arnaud M.; Tavares Da Silva, Fernanda (24 September 2019). ["The how's and what's of vaccine reactogenicity"](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6760227). *npj Vaccines*. **4** (1): 39. [doi](/source/Doi_(identifier)):[10.1038/s41541-019-0132-6](https://doi.org/10.1038%2Fs41541-019-0132-6). [PMC](/source/PMC_(identifier)) [6760227](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6760227). [PMID](/source/PMID_(identifier)) [31583123](https://pubmed.ncbi.nlm.nih.gov/31583123).

1. **[^](#cite_ref-2)** ["DMID Interventional Template"](https://hub.ucsf.edu/sites/g/files/tkssra261/f/DMID_InterventionalTemplate.doc) (docx). NIH. 25 March 2011. Retrieved 30 January 2021.

## External links

[Scholia](https://www.wikidata.org/wiki/Wikidata:Scholia) has a profile for [**reactogenicity (Q7300322)**](https://iw.toolforge.org/scholia/Q7300322).

- [The how’s and what’s of vaccine reactogenicity](https://www.nature.com/articles/s41541-019-0132-6#:~:text=Reactogenicity%20refers%20to%20a%20subset,(or%20'solicited').), *[Nature](/source/Nature_(journal))* (2019)

v t e Artificial induction of immunity / Immunization: Vaccines, Vaccination, Infection, Inoculation (J07) Development Adjuvants Vaccine ingredients list Mathematical modelling Storage Timeline Trials Classes Conjugate Inactivated Live Attenuated Heterologous Subunit/component / Peptide / Virus-like particle / Synthetic DNA / mRNA Therapeutic Toxoid Administration Global: GAVI Alliance NITAG SAGE Vaccine wastage Policy Schedule Vaccine injury US: ACIP Vaccine court Vaccines for Children Program VAERS VSD Vaccines Bacterial Anthrax Brucellosis Cholera# Diphtheria# Hib# Leptospirosis Lyme disease‡ Meningococcus# MeNZB NmVac4-A/C/Y/W-135 Pertussis# Plague Pneumococcal# PCV PPSV Q fever Tetanus# Tuberculosis BCG# Typhoid# Ty21a ViCPS Typhus combination: DPT/DTwP/DTaP Td/Tdap research: Clostridioides difficile Group B streptococcal disease Shigellosis Viral Adenovirus Chikungunya Ebola rVSV-ZEBOV Flu# H1N1 (Pandemrix) H5N1 H5N8 LAIV Hantavirus Hepatitis A# Hepatitis B# Hepatitis E HPV# Cervarix Gardasil Japanese encephalitis# Measles# Mpox Mumps# Polio# Sabin Salk Rabies# Rotavirus# Rubella# SARS-CoV-2 Corbevax† Bharat Biotech† CanSino† CoronaVac† EpiVacCorona† Janssen Kostaive Moderna Novavax Oxford–AstraZeneca Pfizer–BioNTech Sanofi–GSK† Sinopharm BIBP† Skycovione† Sputnik V† Valneva† Respiratory syncytial virus (RSV) Smallpox Tick-borne encephalitis# Varicella zoster Chicken pox# Shingles Yellow fever# combination: Hepatitis A and B Influenza and COVID-19 MMR MMRV research: Cytomegalovirus Dengue# Epstein–Barr virus Hepatitis C Herpes simplex HIV Zika Protozoan Malaria RTS,S research: Trypanosomiasis Helminthiasis research: Hookworm Schistosomiasis Other Androvax (androstenedione albumin) Cancer vaccines ALVAC-CEA BCG# Hepatitis B# HPV# Cervarix Gardasil Prostvac NicVAX Ovandrotone albumin (Fecundin) TA-CD TA-NIC combination: DTaP-IPV/Hib DTaP-IPV-HepB DTwP-HepB-Hib Hexavalent vaccine Inventors/ researchers Edward Jenner Louis Pasteur Hilary Koprowski Jonas Salk John Franklin Enders Maurice Hilleman Stanley Plotkin H. Fred Clark Paul Offit Katalin Karikó Drew Weissman Controversy General MMR (Lancet MMR autism fraud) NCVIA Pox party Thiomersal Vaccines and SIDS Cedillo v. Secretary of Health and Human Services Alternative vaccination schedule 2000 Simpsonwood CDC conference Related Epidemiology Eradication of infectious diseases Vaccinate Your Family List of vaccine topics #WHO-EM ‡Withdrawn from market Clinical trials: †Phase III §Never to phase III

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Adapted from the Wikipedia article [Reactogenicity](https://en.wikipedia.org/wiki/Reactogenicity) by Wikipedia contributors ([contributor history](https://en.wikipedia.org/wiki/Reactogenicity?action=history)). Available under [Creative Commons Attribution-ShareAlike 4.0 International](https://creativecommons.org/licenses/by-sa/4.0/). Changes may have been made.